ISO 27020:2019

Name: ISO 27020:2019 — Dentistry — Brackets and tubes for use in orthodontics
SKU: ISO 27020:2019
Price: 25 EUR
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Dentistry — Brackets and tubes for use in orthodontics

Название (английский):

ISO 27020:2019

Dentistry — Brackets and tubes for use in orthodontics

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 12
Дата публикации:: 7 июня 2019 г.
Издание:: ISO IS 27020 edition 2 version 1
ICS:: 11.060.20

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Описание (английский):

This document specifies requirements and test methods to compare the functional dimensions of orthodontic brackets and tubes and their chemical ion release, as well as packaging and labelling information. This document is applicable to brackets and tubes for use in fixed orthodontic appliances. This document does not specify specific qualitative and quantitative requirements for freedom from biological hazards; which are covered in ISO 10993‑1 and ISO 7405.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

ISO 27020:2019 - Dentistry - Brackets and tubes for use in orthodontics is an international standard that defines requirements and test methods for fixed orthodontic brackets and tubes. It standardizes how to report functional dimensions, angular values, chemical ion release from metallic components, and required packaging and labelling information. The document helps clinicians, manufacturers and testing laboratories make meaningful comparisons between products and supports consistent product information for procurement and regulatory review.

Key Topics and Requirements

Scope: Applies to brackets and tubes used in fixed orthodontic appliances; does not replace biological safety standards (see Related Standards).

Dimensions & angles: Specifies measurement and reporting of key geometric parameters to the nearest 0.01 mm (dimensions) and 1° (angles), including:

in‑out distance
slot depth, slot height, slot length
auxiliary slot dimensions
angle of torque, angulation, and rotational offset

Measurement methods: Type tests on representative samples using callipers, micrometers, optical comparators or equivalent with an accuracy of 0.005 mm or 0.5°; detailed procedures for constructing reference planes and measuring angles and distances are defined.

Chemical ion release (corrosion testing): Introduces a static immersion corrosion test (added in this edition) and records release from metallic brackets as μg/20 brackets/7 days and from metallic tubes as μg/8 tubes/7 days (reported to the nearest 10 μg). Total and per-element releases are to be recorded.

Hazardous elements: Manufacturers must state mass-fraction concentrations for cadmium, beryllium, lead and nickel.

Packaging & labelling: Defines general packaging and labelling information that must be supplied to users.

Type tests: All tests are type tests to verify representative product batches.

Practical Applications & Users

ISO 27020:2019 is useful for:

Orthodontic manufacturers and designers - to verify dimensional conformity and corrosion performance and to prepare compliant technical documentation and labels.

Dental test laboratories - to perform standardized dimensional and corrosion tests and produce comparable test reports.

Clinicians and purchasing managers - to compare product specifications objectively when selecting brackets and tubes.

Regulatory and conformity assessment bodies - for evaluation of device information and performance claims.

Keywords: ISO 27020:2019, orthodontic brackets, orthodontic tubes, bracket dimensions, ion release testing, static immersion corrosion, dental standards.

ISO 27020:2019

Abstract

Похожие стандарты

Overview

Key Topics and Requirements

Practical Applications & Users

Related Standards

Технические детали

ISO 10271:2011

Dentistry — Corrosion test methods for metallic materials

ISO 10993-12:2012

Biological evaluation of medical devices — Part 12: Sample preparation and reference materials

ISO 7405:2018

Dentistry — Evaluation of biocompatibility of medical devices used in dentistry

ISO 19426-7:2021

Structures for mine shafts — Part 7: Rope guides